1. Field of the Invention
The present invention relates to parenteral fluid transfer apparatus having a body member through which fluids are parenterally delivered to and/or withdrawn from a patient (human or animal) through venipuncture or the like. More particularly, this invention is directed to such apparatus having a needle and a self-blunting mechanism.
2. Related Art
For reasons which have received wide publicity, there is substantial demand for self-blunting venipuncture products which may be employed by healthcare workers with minimal risk of incurring accidental needle-stick wounds. A highly successful venipuncture product of this nature is sold under the trademark PUNCTUR-GUARD(copyright) by Bio-Plexus, Inc. of Vernon, Conn. The PUNCTUR-GUARD(copyright) blood collection needle assembly is manufactured in accordance with the teachings of U.S. Pat. No. 4,828,547, issued on May 9, 1989 to Carl R. Sahi et al, the disclosure of which is hereby incorporated herein by reference. In the PUNCTUR-GUARD(copyright) product, a tubular blunting member is disposed within the bore of a needle, i.e., a needle cannula having a conventional beveled tip suitable for penetrating tissue to initiate venipuncture. The blunting member and needle combination of the syringe is initially in an insertion configuration, in which the tissue puncture tip of the needle extends beyond the blunt tip of the blunting member, so normal penetration of the needle into tissue is not affected. The user takes a conventional finger and thumb grip on the barrel finger rest and plunger thumb rest to manipulate the needle. After venipuncture has been achieved, but prior to removal of the needle from the patient, the user advances the syringe plunger relative to the needle by applying thumb and finger pressure to the thumb and finger rests, thus advancing the blunting member so that the tip of the blunting member extends beyond the tissue-penetrating tip of the needle. In this extended configuration of the blunting member and needle combination, the needle tip is effectively blunted to thereby prevent accidental needle-stick wounds upon or after removal of the needle from the patient. Such an arrangement offers the advantages of being economical, reliable and simple in construction and in use.
Another known, commercially available device that makes use of a self-blunting needle assembly is a blood collection needle. The needle assembly comprises a needle cannula mounted in a hub. The hub is configured to engage a standard blood collection tube holder. The assembly comprises a blunting component that comprises a hub having a tubular member extending therethrough. One portion of the tubular member (referred to as the blunting member) extends from the blunting component hub, terminates with a blunt end, and is configured to be slidably received within the needle cannula. The other end of the tubular member extends from the blunting component hub in the opposite direction and terminates with a puncture tip for puncturing the seal on a conventional blood collection vial. The blunting component hub slidably engages the needle component hub and is movable from a retracted position in which the blunt end of the tubular member is within the needle cannula, placing the assembly in a sharpened, insertion configuration, to an extended position in which the blunt end of the tubular member extends beyond the tip of the needle cannula, thus blunting the needle and placing the assembly in a blunted configuration. A groove and detent arrangement between the needle hub and the blunting component hub secures the assembly in the blunted configuration. The assembly is secured in the holder in the insertion configuration. The user grasps the collection tube holder to insert the needle cannula into a patient""s vein. Then, a blood collection tube is inserted into the holder and the puncture tip of the tubular member penetrates the seal on the vial, permitting blood to flow into the tube. To blunt the needle, the user pushes the collection vial further into the holder, causing the seal to bear upon the blunting component hub and to advance the blunting component into the extended position to blunt the needle assembly.
The art shows attempts to reduce the accidental needle-stick danger associated with the use of other medical sharps as well, often by the use of exterior sheathing devices such as that of McCormick et al, U.S. Pat. No. 5,176,655. Other medical sharps devices employing needle-sheathing devices are illustrated by Dombrowski et al U.S. Pat. No. 4,790,828; Dombrowski et al U.S. Pat. No. 4,978,344; Vaillancourt U.S. Pat. No. 4,804,371; and Karczmer U.S. Pat. No. 4,795,432.
U.S. Pat. No. 4,627,841 to Dorr, issued on Dec. 9, 1986, discloses an infusion needle having a needle mounted in a hub and a hollow blunting member mounted in a hub and being telescopically received within the needle. A spring pulls the hubs together, causing the forward end of the blunting member to extend beyond the needle tip. The rearward end of the blunting member is secured to a tube or other fluid flow device. The device comprises wings that carry wedges and that are folded towards each other to provide a haft by which the user manipulates the needle. When the wings are folded towards each other, the wedges are driven between the needle hub and the blunting member hub, thereby separating the hubs by overcoming resistance of the spring and causing the blunting member to retract into the needle.
Generally, the present invention overcomes the above-discussed and other deficiencies and disadvantages of the prior art by providing novel and improved parenteral fluid flow apparatuses for subcutaneous delivery of fluids to, and/or withdrawal of fluids from, a patient.
One broad aspect of the present invention provides a needle apparatus comprising a cannula component comprising a needle cannula and a blunting member. The needle cannula has a longitudinal axis, a puncture tip, and a needle passageway therethrough, and the blunting member has a blunt end. The needle cannula and the blunting member are disposed telescopically one within the other and are configured for movement (i) from an insertion configuration in which the puncture tip of the needle cannula extends beyond the blunt end of the blunting member, (ii) to a blunted configuration in which the blunt end of the blunting member extends beyond the puncture tip to blunt the apparatus. There is a haft connected to the cannula for use in manipulating the cannula component, and an oblique motion deployment means for moving the apparatus from the insertion configuration to the blunted configuration independently of the function of the haft means.
A needle apparatus in accordance with the present invention may have a fluid flow passageway therethrough and may comprise a needle component having a needle component passageway therethrough and comprising a hub portion and a needle cannula, the needle cannula having a longitudinal axis and being joined to, and extending from, the hub portion and having a proximal end and a puncture tip. There is also a blunting component comprising a blunting member having a proximal end and a blunt distal end, the blunting component being dimensioned and configured to be received in the needle component passageway. The blunting component and the needle component are movable relative to each other from an insertion configuration, in which the puncture tip of the needle cannula extends beyond the blunt end of the blunting member, to a blunted configuration, in which the blunt distal end of the blunting member protrudes beyond the puncture tip of the needle cannula, thus blunting the needle cannula. There is an oblique motion deployment means for moving the apparatus from the insertion configuration to the blunted configuration, and a haft connected to the needle component for use in manipulation of the needle cannula without moving the apparatus from the insertion configuration to the blunted configuration.
According to one aspect of the invention, the oblique motion deployment means may comprise a screw thread engagement between the blunting component and the needle component. Alternatively, the oblique motion deployment means may comprise a pliant portion of the needle component configured to be compressible by the user. The blunting component may be dimensioned and configured to move from the insertion configuration to the blunted configuration upon compression of the pliant portion of the needle component. Optionally, the apparatus may comprise a fluid flow passageway therethrough and the pliant portion may comprise a working fluid reservoir, the working fluid being isolated from the fluid flow passageway, and wherein the deployment means comprises a piston and cylinder engagement of the blunting component and the needle component.
According to another aspect of the invention, an apparatus may comprise deployment means comprising a drive member in articulated connection with at least one, optionally both, of the blunting component and the needle component. For example, the drive member may rotatably engage the needle component. Optionally, the drive member is rotatable about an axis that is aligned with the longitudinal axis of the needle cannula. In one embodiment, the blunting component may comprise a shuttle portion and the drive member may comprise a cam surface that bears upon the shuttle portion. The apparatus may be configured to permit the shuttle portion to serve as a cam follower to move the apparatus from the insertion configuration to the blunting configuration in response to rotation of the drive member relative to the needle component. Alternatively, the drive member may be rotatable about an axis that is disposed transversely to the longitudinal axis of the needle cannula.
In another embodiment, the drive member may comprise a contrary motion linkage between the blunting component and the needle component such as a lever or a diverted tension line.
In a particular embodiment, the deployment means may comprise a stored energy means and a release mechanism.
According to another aspect of this invention, the apparatus may comprise locking means for locking the apparatus in the blunted configuration. The locking means may comprise a spline and cam channel engagement between the blunting component and the needle component.
In some embodiments, the apparatus comprises a blunting component and the needle component disposed in a tandem configuration wherein the blunting component defines the proximal aperture of the apparatus. In other embodiments, the drive member is disposed in tandem relation to the needle component and defines the proximal aperture of the apparatus. In still other embodiments, the needle component defines the proximal aperture of the apparatus.
In one particular embodiment, the apparatus may comprise a pair of wings that are connected to the needle component. The wings may be displaceable about a displacement axis that is aligned with the longitudinal axis of the needle cannula and may be movable between a manipulation position and a neutral position. There may be a tension line secured to the wings and connected to the blunting component, the tension line being configured so movement of the wings from the manipulation position to the neutral position causes the tension line to move the apparatus from the insertion configuration to the blunted configuration.
Another broad aspect of this invention provides a needle apparatus comprising a needle component comprising a hub portion and a needle cannula, the needle cannula being joined to, and extending from, the hub portion and having a proximal end and a puncture tip, and defining a longitudinal axis, the hub portion and the needle cannula cooperating to define a needle component passageway for fluid flow therethrough. There is a blunting component comprising a blunting member having a blunt distal end and a proximal end, the blunting member being disposed in coaxial relation to the needle cannula. The blunting component and the needle component are movable relative to each other from an insertion configuration, in which the puncture tip of the needle cannula extends beyond the blunt end of the blunting member, to a blunted configuration, in which the blunt distal end of the blunting member protrudes beyond the puncture tip of the needle cannula, thus blunting the needle cannula. The apparatus includes locking means comprising a spline and a cam channel, for locking the apparatus in the blunted configuration.
In one embodiment, the cam channel may comprise a catch portion, the apparatus comprising catching means for moving the spline into the catch portion of the channel. The catching means may comprise a slide surface in the cam channel. Optionally, the blunting component may comprise a driving means for engaging the needle component and the blunting member and for moving the apparatus from the insertion configuration to the blunted configuration.
Still another broad aspect of this invention provides a needle apparatus having a fluid flow passageway therethrough extending from a first aperture to a second aperture comprising a needle component comprising a needle cannula mounted on a needle hub and a blunting member mounted on a blunting member hub. The needle cannula comprises a puncture tip that defines the first aperture of the apparatus. The needle component and the blunting member component are configured to be received one within the other to provide an outer component and an inner, movable component. The blunting component and the needle component are movable between an insertion configuration in which the tip of the needle extends beyond the blunt end of the blunting member to a blunted configuration in which the blunt tip extends beyond the needle tip to obscure the needle tip and thus blunt the apparatus. The outer component defines the second aperture of the apparatus and further comprises an access aperture. The inner component comprises a lug that protrudes through the access aperture for manipulation by the user to permit the user to move the apparatus from the insertion configuration to the blunted configuration.
Another aspect of this invention relates to a needle apparatus comprising (a) a body member having a longitudinal axis, a proximal end and a distal end, and a longitudinal body passageway extending therethrough and connecting the proximal end and the distal end of the body member in fluid flow communication with each other; (b) a cannula component carried on the body member and disposed therein in fluid flow communication with the body passageway, the cannula component comprising a needle member and a blunting member, the needle member having a tissue puncture tip and a needle proximal end, and the blunting member having a blunting tip and a blunting member proximal end, the needle member and the blunting member being arranged with their respective tips facing in the same direction, and telescopically one within the other for relative axial movement of the needle member and the blunting member from (i) an insertion configuration of the cannula component, in which the puncture tip extends beyond the blunting tip, to (ii) a blunted configuration of the cannula component, in which the blunting tip extends beyond the tissue puncture tip to blunt the same; (c) a shuttle member mounted for axial movement within the body passageway, the shuttle member (1) being dimensioned and configured to provide a first fluid flow passageway extending therethrough, and (2) engaging one of the blunting member and the needle member whereby axial movement of the shuttle member causes axial movement of the blunting member and needle member relative to each other to change the cannula component from its insertion configuration to its blunted configuration; and (d) a drive member in the body passageway which (1) is manipulable from exteriorly of the body member, (2) is dimensioned and configured to leave the body passageway open to fluid flow between the proximal and distal ends of the body member, and (3) is operatively connected to the shuttle member, whereby manipulation of the drive member moves the shuttle member axially through the body passageway, thereby changing the cannula component from its insertion configuration to its blunted configuration, without significant hydraulic effect on biologic fluid in the apparatus.
The drive member may comprise a cam surface and the shuttle may comprise a following surface. The apparatus may further comprise an actuator connected to the drive member and accessible for manipulation thereof from exteriorly of the body member, the drive member (1) being mounted for rotation within the body passageway, (2) being rotatable therein by manipulation of the actuator, and (3) operatively engaging the shuttle member, wherein manipulation of the actuator rotates the drive member to impose force on the following surface via the cam surface to move the shuttle member axially along the body passageway, thereby changing the cannula component from its insertion configuration to its blunted configuration. In a particular embodiment, the needle member may be mounted on the body member and the blunting member may be mounted on the shuttle member and may be disposed telescopically within the needle member.
There may be locking means comprising a spline member and cam channel engagement of the blunting component and the needle component, the cam channel comprising an axially extending guide channel and a catch portion that connects with the guide channel at a lateral channel entryway, and the catch portion extending transversely of the guide channel and comprising a backward stop surface;
wherein the spline member is dimensioned and configured to traverse the guide channel as the blunting component moves from the insertion configuration to the blunted configuration; and
wherein the following surface of the shuttle member and the cam surface of the drive member are each dimensioned and configured so that rotation of the drive member in one direction advances the spline member along the guide channel and into the catch portion for engagement therewith, and rotation of the drive member in the opposite direction effectively disengages the cam follower and the cam surface, thereby locking the apparatus in the blunted configuration.
There may be an air- and liquid-tight sealant sheath disposed over the body member.
Yet another aspect of the invention relates to a needle apparatus comprising a hollow body, the body having a proximal end and a distal end and defining a cavity extending along a body axis from the proximal end to the distal end of the body. The cavity includes a first generally conical region disposed at the distal end of the body, a first generally cylindrical region coaxially disposed adjacent the first conical region, a second generally cylindrical region coaxially disposed adjacent the first cylindrical region, a second generally conical region coaxially disposed adjacent the second cylindrical region and a third generally cylindrical region coaxially disposed adjacent the second conical region and extending therefrom to the proximal end of the body, the diameter of the second cylindrical region being less than that of the first cylindrical region and the diameter of the third cylindrical region being greater than that of the second cylindrical region. There is a cannula having a forward end and a terminal end, the outer diameter of the cannula being substantially equal to the diameter of the first cylindrical region of the cavity, the terminal end of the cannula being received within the, first cylindrical region such that the forward end extends forwardly of the distal end of the body and the cannula extends along the body axis. There is also a movable member means being at least partially disposed within the body cavity and having a forward end and an outer diameter which is not greater than either of the inner diameter of the cannula or the diameter of the second cylindrical region of the cavity, the movable member extending through the second cylindrical region of the cavity and being at least partially movably received within the cannula. One of the forward end of the cannula the forward end of the movable member having a tissue puncture tip and the other of the forward end of the cannula or the forward end of the movable member having a blunt tip.
The locking means of the foregoing devices may optionally comprise a detent on one of the needle component and the blunting component, and a ramp on the other. The ramp may define a shoulder, and the detent is positioned and configured to ride up the ramp as the blunting member is advanced to be positioned to bear against the shoulder to inhibit rearward movement after the blunted configuration is attained.
Independently, the locking means may comprise a detent and an axially-extending slot arrangement wherein the detent is positioned and configured to move axially in the slot as the blunting member is advanced. The slot may be configured to define a pinch region through which the detent passes, the pinch region being configured to inhibit entry of the detent into the slot once the blunted configuration is attained.
In either case, there may optionally be a return ramp for permitting the detent to move axially past the shoulder so that the apparatus can return to the sharpened configuration.
Any of the foregoing embodiments may comprise locking means, optionally comprising a spline and cam channel, for locking the apparatus in the blunted configuration.